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`UNITED STATES SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`Form 10K
`ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`For the fiscal year ended December 31, 2015
`
`or
`TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`Commission file number: 0-19311
`
`BIOGEN INC.
`
`(Exact name of registrant as specified in its charter)
`
`33-0112644
`Delaware
`
`(I.R.S. Employer Identification No )
`(State or other jurisdiction of incorporation or organization)
`225 Binney Street, Cambridge, Massachusetts 02142
`(617) 679-2000
`(Address, including zip code, and telephone number, including area code, of Registrant’s principal executive offices)
`Securities registered pursuant to Section 12(b) of the Act:
`
`Title of Each Class
`Name of Each Exchange on Which Registered
`Common Stock, $0.0005 par value
`The Nasdaq Global Select Market
`
`Securities registered pursuant to Section 12(g) of the Act:
`None
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes No
`Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act
`of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to
`such filing requirements for the past 90 days. Yes No
`Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data
`File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the
`registrant was required to submit and post such files): Yes No
`Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K is not contained herein, and will not be
`contained, to the best of the registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-
`K or any amendment to this Form 10-K.
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting
`company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
`
`Large accelerated filer
`Accelerated filer
`Non-accelerated filer
` Smaller reporting company
`
`
`
`(Do not check if a smaller reporting company)
`
`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes No
`The aggregate market value of the registrant’s common stock held by non-affiliates of the registrant (without admitting that any person whose
`shares are not included in such calculation is an affiliate) computed by reference to the price at which the common stock was last sold as of the last
`business day of the registrant’s most recently completed second fiscal quarter was $94,898,425,323.
`As of January 29, 2016, the registrant had 218,672,717 shares of common stock, $0.0005 par value, outstanding.
`DOCUMENTS INCORPORATED BY REFERENCE
`Portions of the definitive proxy statement for our 2016 Annual Meeting of Stockholders are incorporated by reference into Part III of this report.
`
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`Page 1 of 167
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`Biogen Exhibit 2091
`Coalition v. Biogen
`IPR2015-01993
`
`
`
`Table of Contents
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`
`
`BIOGEN INC.
`ANNUAL REPORT ON FORM 10K
`For the Year Ended December 31, 2015
`TABLE OF CONTENTS
`
`PART I
`
`Page
`
`Item 1.
`Item 1A.
`Item 1B.
`Item 2.
`Item 3.
`Item 4.
`
`
`Item 5.
`Item 6.
`Item 7.
`Item 7A.
`Item 8.
`Item 9.
`Item 9A.
`Item 9B.
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`
`Item 10.
`Item 11.
`Item 12.
`Item 13.
`Item 14.
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`Item 15.
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`Business
`Risk Factors
`Unresolved Staff Comments
`Properties
`Legal Proceedings
`Mine Safety Disclosures
`
`PART II
`Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities
`Selected Financial Data
`Management’s Discussion and Analysis of Financial Condition and Results of Operations
`Quantitative and Qualitative Disclosures About Market Risk
`Financial Statements and Supplementary Data
`Changes in and Disagreements with Accountants on Accounting and Financial Disclosure
`Controls and Procedures
`Other Information
`
`PART III
`Directors, Executive Officers and Corporate Governance
`Executive Compensation
`Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
`Certain Relationships and Related Transactions, and Director Independence
`Principal Accounting Fees and Services
`
`Exhibits and Financial Statement Schedules
`
`PART IV
`
`
`
`Signatures
`Consolidated Financial Statements
`Exhibit Index
`
`1
`32
`43
`44
`45
`45
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`46
`48
`50
`81
`83
`83
`84
`84
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`86
`86
`86
`86
`86
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`87
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`88
`F- 1
`A- 1
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`Table of Contents
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`NOTE REGARDING FORWARDLOOKING STATEMENTS
`This report contains forward-looking statements that are being made pursuant to the provisions of the Private Securities Litigation Reform Act
`of 1995 (the Act) with the intention of obtaining the benefits of the “Safe Harbor” provisions of the Act. These forward-looking statements may be
`accompanied by such words as “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “project,” “target,”
`“will” and other words and terms of similar meaning. Reference is made in particular to forward-looking statements regarding:
`the anticipated amount, timing and accounting of revenues, contingent payments, milestone, royalty and other payments under licensing,
`•
`collaboration or acquisition agreements, tax positions and contingencies, collectability of receivables, pre-approval inventory, cost of sales,
`research and development costs, compensation and other selling, general and administrative expenses, amortization of intangible assets,
`foreign currency exchange risk, estimated fair value of assets and liabilities, and impairment assessments;
`expectations, plans and prospects relating to sales, pricing, growth and launch of our marketed and pipeline products;
`the potential impact of increased product competition in the markets in which we compete;
`patent terms, patent term extensions, patent office actions and expected availability and period of regulatory exclusivity;
`the costs and timing of potential clinical trials, filing and approvals, and the potential therapeutic scope of the development and
`commercialization of our and our collaborators’ pipeline products;
`the drivers for growing our business, including our plans and intent to commit resources relating to business development opportunities and
`research and development programs;
`the anticipated benefits, cost savings, and charges related to our corporate restructuring initiatives;
`our manufacturing capacity, use of third-party contract manufacturing organizations and plans and timing relating to the expansion of our
`manufacturing capabilities, including anticipated investments and activities in new manufacturing facilities;
`the impact of the continued uncertainty of the credit and economic conditions in certain countries in Europe and our collection of accounts
`receivable in such countries;
`the potential impact of healthcare reform in the United States (U.S.) and measures being taken worldwide designed to reduce healthcare costs
`to constrain the overall level of government expenditures, including the impact of pricing actions and reduced reimbursement for our products;
`the timing, outcome and impact of administrative, regulatory, legal and other proceedings related to patents and other proprietary and intellectual
`property rights, tax audits, assessments and settlements, pricing matters, sales and promotional practices, product liability and other matters;
`lease commitments, purchase obligations and the timing and satisfaction of other contractual obligations;
`our ability to finance our operations and business initiatives and obtain funding for such activities; and
`the impact of new laws and accounting standards.
`These forward-looking statements involve risks and uncertainties, including those that are described in the “Risk Factors” section of this report,
`and elsewhere in this report that could cause actual results to differ materially from those reflected in such statements. You should not place undue
`reliance on these statements. Forward-looking statements speak only as of the date of this report. Except as required by law, we do not undertake
`any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.
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`Page 3 of 167
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`Table of Contents
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`NOTE REGARDING COMPANY AND PRODUCT REFERENCES
`Throughout this report, “Biogen,” the “Company,” “we,” “us” and “our” refer to Biogen Inc. (formerly Biogen Idec Inc.) and its consolidated
`subsidiaries. References to “RITUXAN” refer to both RITUXAN (the trade name for rituximab in the U.S., Canada and Japan) and MabThera (the
`trade name for rituximab outside the U.S., Canada and Japan), and “ANGIOMAX” refers to both ANGIOMAX (the trade name for bivalirudin in the
`U.S., Canada and Latin America) and ANGIOX (the trade name for bivalirudin in Europe).
`NOTE REGARDING TRADEMARKS
`ALPROLIX®, AVONEX®, BENEPALI®, ELOCTATE®, FLIXABI®, PLEGRIDY®, RITUXAN®, TECFIDERA® and TYSABRI® are registered
`trademarks of Biogen. FUMADERMTM and ZINBRYTATM are trademarks of Biogen. Other trademarks referenced in this report are the property of
`their respective owners.
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`Item 1. Business
`
`PART I
`
`Overview
`Biogen is a global biopharmaceutical company focused on discovering, developing, manufacturing and delivering therapies to patients for the
`treatment of neurodegenerative diseases, hematologic conditions and autoimmune disorders.
`Our marketed products include TECFIDERA, AVONEX, PLEGRIDY, TYSABRI and FAMPYRA for multiple sclerosis (MS), ELOCTATE for
`hemophilia A and ALPROLIX for hemophilia B, and FUMADERM for the treatment of severe plaque psoriasis. We also have a collaboration
`agreement with Genentech, Inc. (Genentech), a wholly-owned member of the Roche Group (Roche Group), which entitles us to certain business and
`financial rights with respect to RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL) and other conditions,
`GAZYVA indicated for the treatment of CLL, and other potential anti-CD20 therapies.
`We support our drug discovery and development efforts through the commitment of significant resources to discovery, research and
`development programs and business development opportunities, particularly within areas of our scientific, manufacturing and technical expertise and
`scientific adjacencies. In addition to our innovative drug development efforts, we aim to leverage our manufacturing capabilities and scientific
`expertise to extend our mission to improve the lives of patients living with serious diseases through the development, manufacture and marketing of
`biosimilars through Samsung Bioepis, our joint venture with Samsung BioLogics Co. Ltd. (Samsung Biologics).
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`Key Developments
`During 2015 and early 2016, we had a number of key developments affecting our business.
`Corporate Matters
`Company Name Change
`In March 2015, we changed our name from Biogen Idec Inc. to Biogen Inc.
`Corporate Restructuring
`In October 2015, we announced a corporate restructuring, which includes a reduction in workforce and discontinuation of certain programs. We
`are reinvesting the resulting savings to support key commercial activities and the advancement of our pipeline candidates.
`Capital Allocation
`In 2015, our capital allocation strategy included the following elements:
` Returned approximately $5.0 billion to our shareholders through our share repurchase program
`Share Repurchase
` Utilized a portion of the proceeds from our $6.0 billion senior unsecured debt offering completed in September 2015 to fund
`Program
`our share repurchase program
`
`
` Acquired Convergence Pharmaceuticals (Convergence), a clinical-stage biopharmaceutical company with a focus on
`developing product candidates for neuropathic pain
` Obtained exclusive worldwide license, excluding Asia, from Mitsubishi Tanabe Pharma Corporation (MTPC) to amiselimod
`(MT-1303), a late stage experimental medicine with potential in multiple autoimmune indications
` Entered into a collaboration agreement with Applied Genetic Technologies Corporation (AGTC) to develop gene-based
`therapies for multiple ophthalmic diseases
`
`
` Acquired land in Solothurn, Switzerland, where we plan to build a biologics manufacturing facility in the Commune of
`Luterbach over the next several years
` Acquired the drug product manufacturing facility and supporting infrastructure of Eisai, Inc. (Eisai) in Research Triangle Park
`(RTP), North Carolina
`Corporate Responsibility
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`Acquisitions and
`Collaborations
`
`Investment in
`Manufacturing
`
`Environmental Sustainability
`In 2015, we were named the biotechnology industry leader on the
`Dow Jones Sustainability World Index, an index that tracks the
`economic, environmental and social strategy and performance of the
`2,500 largest companies in the S&P Global Broad Market Index.
`In 2015, we announced that we achieved carbon neutrality,
`meaning we believe we have effectively neutralized all of the carbon
`emissions associated with our business.
`
`Humanitarian Aid
`In 2014, we and Swedish Orphan Biovitrum AB (publ) (Sobi)
`began working with the World Federation of Hemophilia (WFH) to help
`people with hemophilia in the developing world through our pledge to
`donate up to one billion international units (IUs) of clotting factor
`therapy for humanitarian use, of which up to 500 million IUs will be
`donated to WFH USA over a period of five years. In 2015, we made
`the first shipments of hemophilia therapy to WFH USA.
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`Product/Pipeline Developments
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`Multiple Sclerosis
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`ZINBRYTA (daclizumab high yield process)
` In March 2015, the European Medicines Agency (EMA) validated our marketing authorization application (MAA) for ZINBRYTA for the
`treatment of relapsing forms of MS in the European Union (E.U.).
`
` In April 2015, the U.S. Food and Drug Administration (FDA) accepted our Biologics License Application (BLA) for ZINBRYTA for the
`treatment of relapsing forms of MS in the United States (U.S.).
`TYSABRI (natalizumab)
` In July 2015, the results of ACTION, our Phase 2 trial investigating TYSABRI in acute ischemic stroke, did not demonstrate an impact on
`change in infarct volume, the primary endpoint. Exploratory endpoints suggested that TYSABRI had a beneficial impact on patient functional
`deficits.
`
` In October 2015, the results of ASCEND, our Phase 3 study evaluating TYSABRI in secondary progressive MS (SPMS), did not achieve its
`primary and secondary endpoints, and the development of TYSABRI in SPMS was discontinued.
`Anti-LINGO
` In January 2015, we announced top-line results from RENEW, our Phase 2 acute optic neuritis trial.
`Hemophilia
`ELOCTATE [Antihemophilic Factor (Recombinant), Fc Fusion Protein]
` In November 2015, the European Commission (EC) approved ELOCTA, the approved trade name for ELOCTATE in the E.U., for the
`treatment of hemophilia A.
`
` Sobi has assumed final development and commercialization of ELOCTA in their territory, which essentially includes Europe, North Africa,
`Russia, and certain markets in the Middle East (Sobi Territory).
`ALPROLIX [Coagulation Factor IX (Recombinant), Fc Fusion Protein]
` In June 2015, the EMA validated our MAA for ALPROLIX for the treatment of hemophilia B.
`
` In July 2015, Sobi exercised its option to assume final development and commercialization of ALPROLIX in the Sobi Territory.
`Neurodegeneration
`
`Aducanumab (BIIB037)
` In March 2015 and July 2015, we announced data from pre-specified interim analyses of PRIME, our Phase 1b study of aducanumab.
`
` In September 2015, we enrolled our first patient in our two global Phase 3 studies, ENGAGE and EMERGE, to assess the efficacy and
`safety of aducanumab in people with early Alzheimer's disease. In October 2015, we announced that we received FDA agreement on a
`special protocol assessment on the Phase 3 study protocols. Such agreement constitutes FDA’s concurrence on the design and size of the
`clinical trials which will form the basis for approval of aducanumab.
`Other Programs
`
`
`
`Nusinersen (ISIS-SMNRx)
` In June 2015, our collaborator, Ionis Pharmaceuticals, Inc. (Ionis), formerly known as Isis Pharmaceuticals, Inc., announced additional data
`from two Phase 2 studies of nusinersen for the treatment of SMA in infants and children. There are two ongoing Phase 3 studies of
`nusinersen.
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`Genentech Relationships
`
`GAZYVA (obinutuzumab)
` In February 2015, the Roche Group announced positive results from its Phase 3 GADOLIN study of GAZYVA in non-Hodgkin’s lymphoma.
`Ocrelizumab
` In June 2015, the Roche Group announced positive results from two Phase 3 studies evaluating ocrelizumab compared with interferon beta-
`1a in people with relapsing forms of MS.
`
` In September 2015, the Roche Group announced positive results from a Phase 3 study evaluating ocrelizumab in people with primary
`progressive MS (PPMS).
`
` Under our agreement with Genentech, if ocrelizumab is approved, we will receive tiered royalty payments on sales of ocrelizumab.
`Biosimilars (Samsung Bioepis - Biogen's Joint Venture with Samsung Biologics)
`
`
`
`
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`BENEPALI
` In November 2015, Samsung Bioepis received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the
`MAA for BENEPALI, an etanercept biosimilar referencing ENBREL. In January 2016, the EC approved the MAA for BENEPALI for
`marketing in the E.U. Under our agreement with Samsung Bioepis, we will manufacture and commercialize BENEPALI in specified E.U.
`countries.
`FLIXABI
` In March 2015, the EMA validated and accepted Samsung Bioepis’ MAA for FLIXABI, an infliximab biosimilar candidate referencing
`REMICADE.
`
`Discontinued Programs
` During 2015, we discontinued several programs, including our study of Neublastin in neuropathic pain, our Phase 3 program for TECFIDERA
`in SPMS, our Phase 3 program evaluating TYSABRI in SPMS, the development of anti-TWEAK in lupus nephritis, and certain activities in
`immunology and fibrosis research.
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`Marketed Products
`The following graphs show our product sales and unconsolidated joint business revenues by principal product and geography as a percentage of
`revenue for the years ended December 31, 2015, 2014 and 2013.
`
`
`(1) Other includes FAMPYRA, ELOCTATE, ALPROLIX and FUMADERM
`Product sales for TECFIDERA, AVONEX and TYSABRI and unconsolidated joint business revenues for RITUXAN each accounted for more
`than 10% of our total revenue for the years ended December 31, 2015, 2014 and 2013. For additional financial information about our product and
`other revenues and geographic areas in which we operate, please read Note 24, Segment Information to our consolidated financial statements,
`Item 6. Selected Financial Data and Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations included in
`this report. A discussion of the risks attendant to our operations is set forth in the “Risk Factors” section of this report.
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`Product
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`Relapsing forms of MS
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`Relapsing forms of MS in the U.S.
`RRMS in the E.U.
`
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`Relapsing forms of MS
`Crohn's disease in the U.S.
`
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`Walking ability for patients with MS
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`6
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`Indication
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`Relapsing forms of MS in the U.S.
`Relapsing-remitting MS (RRMS) in the E.U.
`
`Multiple Sclerosis
`We develop, manufacture and market a number of products designed to treat patients with MS. MS is a progressive neurological disease in
`which the body loses the ability to transmit messages along nerve cells, leading to a loss of muscle control, paralysis and, in some cases, death.
`Patients with active relapsing MS experience an uneven pattern of disease progression characterized by periods of stability that are interrupted by
`flare-ups of the disease after which the patient returns to a new baseline of functioning. Our MS products and major markets include:
`
`
`Major Markets
`Collaborator
`
`
`None
`U.S.
`United Kingdom
`France
`Germany
`Italy
`
`Spain
`
`U.S.
`United Kingdom
`France
`Germany
`Italy
`
`Spain
`
`U.S.
`United Kingdom
`France
`Germany
`Italy
`
`Spain
`
`U.S.
`United Kingdom
`France
`Germany
`Italy
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`Spain
`
`France
`Germany
`Spain
`Canada
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`None
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`None
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`None
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`Acorda Therapeutics, Inc.
`(Acorda)
`
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`Hemophilia
`We develop, manufacture and market products designed to treat patients with hemophilia A and B. Hemophilia A is caused by having
`substantially reduced or no Factor VIII activity and hemophilia B is caused by having substantially reduced or no Factor IX activity, each of which is
`needed for normal blood clotting. People with hemophilia A and B experience bleeding episodes that may cause pain, irreversible joint damage and
`life-threatening hemorrhages. Prophylactic infusions of Factor VIII or Factor IX, as applicable, temporarily replace clotting factor necessary to control
`bleeding and help protect against new bleeding episodes.
`Our products for hemophilia and major markets include:
`
`Product
`
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`
`
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`Collaborator
`
`Sobi
`
`
`
`
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`Major Markets
`Indication
`
`
`Adults and children with hemophilia A for
`U.S.
`control of bleeding episodes
`
`Japan
`
`
`Adults and children with hemophilia B for
`U.S.
`control of bleeding episodes
` Sobi
`Japan
`In November 2015, the EC approved ELOCTA for the treatment of hemophilia A in the E.U. Under our collaboration agreement with Sobi, Sobi
`has assumed responsibility for final development and commercialization of ELOCTA in the Sobi Territory.
`Genentech Relationships
`We have a collaboration agreement with Genentech that entitles us to certain business and financial rights with respect to RITUXAN, GAZYVA
`and other anti-CD20 product candidates. Current products include:
`
`
`
`Product
`
`
`
`
`Indication
`
`Non-Hodgkin's lymphoma
`CLL
`Rheumatoid arthritis
`Two forms of ANCA-associated vasculitis
`
`In combination with chlorambucil for previously untreated CLL
`
`
`Major Markets
`
`U.S.
`Canada
`
`
`
`U.S.
`
`
`
`For information about our unconsolidated joint business and agreement with Genentech, please read Note 1, Summary of Significant
`Accounting Policies and Note 19, Collaborative and Other Relationships to our consolidated financial statements included in this report.
`Other
`
`Product
`
`
`Indication
`
`Moderate to severe plaque psoriasis
`
`
`Collaborator
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`None
`
`
`
`
`Major Market
`
`Germany
`
`
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`Patient Support and Access
`We interact with patients, advocacy organizations and healthcare
`societies in order to gain insights into unmet needs. The insights
`gained from these engagements help us support patients with services,
`programs and applications that are designed to help patients lead better
`lives. Among other things, we provide customer service and other
`related programs for our products, such as disease and product
`specific websites, insurance research services and order, delivery and
`fulfillment services.
`We are dedicated to helping patients obtain access to our
`therapies. Our patient representatives have access to a comprehensive
`suite of financial assistance tools. With those tools, we help patients
`and their caregivers and healthcare professionals understand, compare
`and select insurance options and programs that are available to them.
`In the U.S., we have established programs that provide qualified
`uninsured or underinsured patients with marketed products at no or
`reduced charge, based on specific eligibility criteria. We also provide
`charitable contr butions that may assist eligible commercially-insured
`patients with out-of-pocket expenses associated with their costs for
`our products.
`
`Table of Contents
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`
`
`Marketing and Distribution
`Sales Force and Marketing
`We promote our products worldwide, including in the U.S., most
`of the major countries of the E.U. and Japan, primarily through our own
`sales forces and marketing groups. In some countries, particularly in
`areas where we continue to expand into new geographic areas, we
`partner with third parties. We focus our sales and marketing efforts on
`specialist physicians in private practice or at major medical centers.
`We use customary pharmaceutical company practices to market our
`products and to educate physicians, such as sales representatives
`calling on individual physicians, advertisements, professional
`symposia, direct mail, public relations and other methods.
`Distribution Arrangements
`We distribute our products in the U.S. principally through
`wholesale distributors of pharmaceutical products, mail order specialty
`distributors or shipping service providers. In other countries, the
`distribution of our products varies from country to country, including
`through wholesale distr butors of pharmaceutical products and third-
`party distribution partners who are responsible for most marketing and
`distribution activities.
`RITUXAN and GAZYVA are marketed and distributed by the
`Roche Group and its sublicensees.
`Our product sales to two wholesale distributors,
`AmerisourceBergen and McKesson, each accounted for more than
`10% of our total revenues for the years ended December 31, 2015,
`2014 and 2013, and on a combined basis, accounted for approximately
`60% of our gross product revenues for such years, respectively. For
`additional information, please read Note 1, Summary of Significant
`Accounting Policies to our consolidated financial statements included
`in this report.
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`Patents and Other Proprietary Rights
`Patents are important to obtaining and protecting exclusive rights
`in our products and product candidates. We regularly seek patent
`protection in the U.S. and in selected countries outside the U.S. for
`inventions originating from our research and development efforts. In
`addition, we license rights to various patents and patent applications.
`U.S. patents, as well as most foreign patents, are generally
`effective for 20 years from the date the earliest application was filed;
`however, U.S. patents that issue on applications filed before June 8,
`1995 may be effective until 17 years from the issue date, if that is later
`than the 20 year date. In some cases, the patent term may be
`extended to recapture a portion of the term lost during regulatory review
`of the claimed therapeutic or, in the case of the U.S., because of
`U.S. Patent and Trademark Office (USPTO) delays in prosecuting the
`application. Specifically, in the U.S., under the Drug Price Competition
`and Patent Term Restoration Act of 1984, commonly known as the
`Hatch-Waxman Act, a patent that covers an FDA-approved drug may
`be eligible for patent term extension (for up to five years, but not
`beyond a total of 14 years from the date of product approval) as
`compensation for patent term lost during the FDA regulatory review
`process. The duration and extension of the term of foreign patents
`varies, in accordance with local law. For example, supplementary
`protection certificates (SPCs) on some of our products have been
`granted in a number of European countries, compensating in part for
`delays in obtaining marketing approval.
`Regulatory exclusivity, which may consist of regulatory data
`protection and market protection, also can provide meaningful
`protection for our products. Regulatory data protection provides to the
`holder of a drug or biologic marketing authorization, for a set period of
`time, the exclusive use of the proprietary pre-clinical and clinical data
`that it created at significant cost and submitted to the applicable
`regulatory authority to obtain approval of its product. After the
`applicable set period of time, third parties are then permitted to rely
`upon our data to file for approval of their abbreviated applications for,
`and to market (subject to any applicable market protection), their
`generic drugs and biosimilars referencing our data. Market protection
`provides to the holder of a drug or biologic marketing authorization the
`exclusive right to commercialize its product for a set period of
`
`9
`
`time, thereby preventing the commercialization of another product
`containing the same active ingredient(s) during that period. Although
`the World Trade Organization's agreement on trade-related aspects of
`intellectual property rights (TRIPS) requires signatory countries to
`provide regulatory exclusivity to innovative pharmaceutical products,
`implementation and enforcement varies widely from country to country.
`We also rely upon other forms of unpatented confidential
`information to remain competitive. We protect such information
`principally through confidentiality agreements with our employees,
`consultants, outside scientific collaborators, scientists whose research
`we sponsor and other advisers. In the case of our employees, these
`agreements also provide, in compliance with relevant law, that
`inventions and other intellectual property conceived by such employees
`during their employment shall be our exclusive property.
`Our trademarks are important to us and are generally covered by
`trademark applications or registrations in the USPTO and the patent or
`trademark offices of other countries. We also use trademarks licensed
`from third parties, such as the trademark FAMPYRA which we license
`from Acorda. Trademark protection varies in accordance with local law,
`and continues in some countries as long as the trademark is used and
`in other countries as long as the trademark is registered. Trademark
`registrations generally are for fixed but renewable terms.
`Our Patent Portfolio
`The following table describes our patents in the U.S. and Europe
`that we currently consider of primary importance to our marketed
`products, including the territory, patent number, general subject matter
`and expected expiration dates. Except as otherwise noted, the
`expected expiration dates include any granted patent term extensions
`and issued SPCs. In some instances, there are later-expiring patents
`relating to our products directed to, among other things, particular
`forms or compositions, methods of manufacturing, or use of the drug in
`the treatment of particular diseases or conditions. We also continue to
`pursue additional patents and patent term extensions in the U.S. and
`other territories covering various aspects of our products that may, if
`issued, extend exclusivity beyond the expiration of the patents listed in
`the table.
`
`Page 13 of 167
`
`
`
`Table of Contents
`
`Product
`TECFIDERA
`
`
`
`
`
`
`
`
`
`
`AVONEX and
`PLEGRIDY
`PLEGRIDY
`
`
`
`
`TYSABRI
`
`
`
`
`
`
`
`FAMPYRA
`
`
`
`ELOCTATE and
`ALPROLIX
`
`
`
`
`
`
`
`ELOCTATE
`
`
`Territory
`
`
` U.S.
` U.S.
` U.S.
` U.S.
` U.S.
` U.S.
` U.S.
` Europe
` Europe
` U.S.
` U.S.
` U.S.
` U.S.
` Europe
` U.S.
`U.S.
`
`
` U.S.
` Europe
` Europe
` Europe
` Europe
` Europe
` U.S.
` U.S.
` U.S.
` U.S.
` Europe
` Europe
` Europe
` U.S.
` U.S.
` U.S.
`
`ALPROLIX
`
`Footnotes follow on next page.
`
`
`Patent No.
` 7,619,001
` 7,803,840
` 8,399,514
` 8,524,773
` 6,509,376
` 8,759,393
` 7,320,999
` 1131065
` 2137537
` 7,588,755
` 7,446,173
` 8,524,660
` 8,017,733
` 1656952
` 5,840,299
`6,602,503
`
`
` 7,807,167
` 0804237
` 1485127
` 0484186
` 1732548
` 23775536
` 7,348,004
` 7,862,820
` 8,329,182
` 7,404,956
` 1624891
` 1625209
` 2298347
` 9,050,318
` 9,241,978
` 9,233,145
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`General Subject Matter
` Methods of treatment
` Methods of treatment
` Methods of treatment
` Methods of treatment
` Formulations of dia kyl fumarates for use in the treatment of
`autoimmune diseases
` Formulations
` Methods of treatment
` Formulations of dia kyl fumarates and their use for treating
`autoimmune diseases
` Methods of use
` Use of recombinant beta interferon for immunomodulation
` Polymer conjugates of interferon beta-1a
` Methods of treatment
` Polymer conjugates of interferon beta-1a
` Polymer conjugates of interferon-beta-1a and uses thereof
` Humanized immunoglobulins; nucleic acids; pharmaceutical
`compositions; methods of use
`Humanized recombinant antibodies; nucleic acids and host
`cells; processes for production; therapeutic compositions;
`
`methods of use
`